Association of Gastrointestinal Motility Disorders, Inc.
AGMD
Heparin Alert
Heparin is an important blood thinner used by millions of people to prevent blood clots. It is manufactured by Baxter International, a large pharmaceutical company. Heparin is an old drug from the 1930s and is derived from pigs’ intestines. Although generics are available, Baxter maintains sales to 50 percent of the U.S. market.
In an effort to reduce costs, many drug companies outsource to suppliers and manufacturers outside of the United States, particularly China. Baxter says that for many years it has been getting the active pharmaceutical ingredient for heparin from an American supplier that operates a plant in China and another in the United States.
During February, FDA received reports of hundreds of serious allergic reactions, and at least four deaths in people using Baxter’s heparin. The agency began an immediate investigation and found that neither the FDA, nor the Chinese drug regulatory authority, had ever inspected the Chinese factory that makes the active ingredient.
Reporters asked the Chinese government about the supplier and were told it is a chemical company, not a drug company, and chemical companies are not inspected. An official from China’s drug safety agency told the Wall Street Journal that, “pharmaceutical ingredients made in China are ultimately the responsibility of the countries that buy them” (“China Says Importing Countries Bear Responsibility for Drug Checks”: G. Fairclough, February 27, 2008, Wall Street Journal).
By the beginning of March, FDA announced that it found a contaminant in Baxter’s heparin, but it could not identify what it was. The number of reported deaths in the United States increased to 19, but the agency could not determine if all the patients had taken Baxter’s heparin or if they had used heparin made by another company.
Baxter has voluntarily withdrawn its heparin from the market. FDA told the Wall Street Journal on March 6 that it was reviewing 785 reports of adverse events in heparin patients.
Dr. Janet Woodcock of the FDA said they do not know whether the contaminant got into the heparin inadvertently, or whether it was actually added. FDA also believes the contamination effected only the most recent production cycle of heparin.
On March 7, the German government reported an outbreak of severe allergic reactions in patients taking heparin. A German company, not Baxter International, manufactured the drug. An investigation into the source of the active ingredients is ongoing.
Bulletin: On March 19, 2008, the FDA announced that it has identified the contaminant in Baxter’s heparin. It is a chemical called over-sulfated chondroitin sulfate, which is a chemically-altered version of the dietary supplement chondroitin sulfate. FDA does not know if it was accidentally or deliberately added to heparin at the Chinese factory. Chondroitin sulfate is made from animal cartilage, and it is chemically related to heparin. This is why it has been difficult to identify. It is less expensive to manufacture than heparin. The FDA also said it cannot yet determine if the contaminant is the cause of the allergic reactions and deaths occurring in heparin users, but it is the only contaminant found in the Baxter product.
Courtesy of the National Organization for Rare Disorders, Inc. (NORD)
FDA - Omeprazole and Esomeprazole
Omeprazole (marketed as Prilosec and generic products)
Omeprazole + Sodium Bicarbonate (marketed as Zegerid)
Nexium (esomeprazole)
Update About The Ongoing Safety Review About A Potential Increased Risk Of Heart Problems For Patients Treated With These Drugs
FDA informed healthcare professionals of the issuance of the Agency's follow-up communication regarding its review of safety data for the drugs omeprazole and esomeprazole that raised concerns about a potential increased risk of heart problems for patients treated with these drugs. The Agency conducted a comprehensive review of the data from two studies that were submitted to FDA. FDA continues to believe that long-term use of omeprazole or esomeprazole is not likely to be associated with an increased risk of heart problems and recommends that healthcare providers continue to prescribe and patients continue to use these products in the manner described in the labeling for the two products. See the "Update of Safety Review" for information regarding the two studies that were reviewed.
Read the complete MedWatch 2007 Safety Summary including a link to the follow-up FDA communication regarding this issue at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Omeprazole
FDA Permits Restricted Use of Zelnorm for Qualifying Patients
The U.S. Food and Drug Administration announced that it is permitting the restricted use of Zelnorm (tegaserod maleate) under a treatment investigational new drug (IND) protocol to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55 who meet specific guidelines.In some instances, patients with a serious or life-threatening disease or condition who are not enrolled in a clinical trial may be treated with a drug not approved by the FDA. Generally, such use is allowed within guidelines called a treatment IND, when no comparable or satisfactory alternative drug or therapy is available.
In addition to the age and gender restrictions, the IND protocol for Zelnorm limits use of the drug to those with IBS-C or CIC whose physicians decide the drug is medically necessary. Patients must sign consent materials to ensure they are fully informed of the potential risks and benefits of Zelnorm.
On March 30, 2007, the FDA asked Novartis, the manufacturer of Zelnorm, to suspend its U.S. marketing and sales because a safety analysis found a higher chance of heart attack, stroke, and unstable angina (heart/chest pain) in patients treated with Zelnorm compared with treatment with an inactive substance (placebo).
At that time, the FDA indicated that there might be patients for whom the benefits of Zelnorm treatment outweigh the risks and for whom no other treatment options were available. FDA committed to work with Novartis to allow access to Zelnorm for those patients through a special program. That work yielded this IND protocol.
"These patients must meet strict criteria and have no known or pre-existing heart problems and be in critical need of this drug," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research (CDER). "Zelnorm will remain off the market for general use."
Irritable bowel syndrome is a disorder characterized most commonly by cramping, abdominal pain, bloating, constipation, and diarrhea. IBS causes a great deal of discomfort and distress, but it does not permanently harm the intestines and does not lead to disease. For some people, however, IBS can be disabling. They may be unable to work, attend social events, or even travel short distances.
Patients are considered to have chronic constipation if they have fewer than three complete spontaneous bowel movements per week and at least one of the following symptoms for at least 25 percent of those bowel movements: straining, hard stools, incomplete evacuation.
Physicians with IBS-C or CIC patients who meet the IND criteria should contact Novartis at 888- 669-6682 or 866-248-1348. Those who do not qualify for the Zelnorm treatment protocol may contact FDA’s Division for Drug Information about other options at 888-463-6332.
For more information:
Novartis Zelnorm Web page
For more information, click the link below:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Zelnorm
Copyright - 2008
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